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Job Details

(Sr) Country Submission Specialist, Spain or Portugal

Company: inVentiv Health Clinical
Location:
Reference: 13534
Closing Date: 09 Dec 16
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Join Site Centricity Unit within inVentiv Health Clinical in Spain as a (Senior) Country Submission Specialist. We offer you unique opportunity to work both in Spain and Portugal! See and get to know us better - https://youtu.be/YQgaDu0L-CQ.

Requirements:

Position: (Senior) Country Submission Specialist

Location: home-based, Spain

Contract: Permanent, full-time

 

Main responsibilities

  • Conduct research and maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission approvals, and subsequent follow-up documentation and providing updates of local processes and requirements to the Regulatory Intelligence portal.
  • Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions.
  • Compile and submit CTAs to Regulatory Authorities and IRB/EC (if applicable)
  • Complete review of CTAs prior to submission to Regulatory Authorities and IRB/EC as part of internal QC process.
  • Customize country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents.
  • Complete review of essential documents following Essential Document Checklist QC.
  • Review translations of regulatory documents.
  • Provide regular local status updates to SSU Project Lead; update appropriate study-tracking tools with local essential document and ethics committee status, and maintain project tracking systems for assigned projects.
  • Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.
  • Support other departments as necessary
  • Identify site issues during start-up process; resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues.
  • Mentor junior staff on local regulations and internal procedures.
  • Support the development of start-up plans and essential document checklists.
  • May play the role of Country Expert for internal intelligence collection and training purposes.
  • Lead a single-country/domestic study by providing work direction and oversight to a team.
  • Act as study start-up project lead on projects with limited scope establishing the CTA submission strategy (Regulatory Authorities and IRB/EC).
  • Act as Subject Matter Expert (SME) for a specific function of EDCS in a specific project or region
  • Complete assigned training programs and applying learning.
  • Complete necessary administrative tasks.
  • May perform other duties as assigned.

 

Requirements

  • Minimum five (5) years clinical research/monitoring experience including four (4) years study start-up experience
  • Minimum 1 year of experience in submissions in Portugal.
  • Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Strong organizational skills
  • Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
  • Ability to work independently in a fast-paced environment with a sense of urgency to match the pace
  • Must demonstrate excellent computer skills
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
  • Occasional travel may be required.

Apply for this job: (Sr) Country Submission Specialist, Spain or Portugal

Contact Information:

Address:  Poland (Polska)
Ul. Nowogrodzka 68
02-014 Warsaw (Warszawa)

Poland
Reasons to work for inVentiv Health Clinical
Website:  Visit Our Web Site

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